Indianapolis, Indiana 46202


Purpose:

Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.


Study summary:

The long-term goal for this project is to establish a model of alcohol seeking despite aversion (SDA) as a platform for the laboratory testing of novel pharmacologic and behavioral interventions that can be used among those with the highest risk, but who have yet to progress to treatment-resistant drinking. The objective of this application is to test SDA across multiple levels of analysis. The investigators consider SDA as an early marker of alcohol use disorder progression that is related to lifetime drinking history, alcohol use disorder risks, and brain physiology. The investigators have completed a pilot study demonstrating that SDA can be objectively quantified via an intravenous alcohol self-administration task, in which operant work for identical incremental alcohol rewards is paired with aversive stimuli. This preliminary data supports the central hypotheses that behavior in the SDA model is attributable to lifetime alcohol exposure, is related to alcohol use disorder risk factors and phenotypes, and reflects alterations in neural system function. In this project, SDA will be measured along with recent drinking history, negative affect-based rash action (i.e. negative urgency, including action with respect to alcohol use), and self-rating of the effects of alcohol. The rationale for this work is that it would lead to the first objective, well-validated measure of SDA in humans.


Criteria:

Inclusion Criteria: - Higher or lower lifetime alcohol drinking history - Able to understand and complete questionnaires and procedures in English - BMI between 18.5 and 32 - Willing and able to tolerate iv placement - Right-handed (for fMRI Arm only) Exclusion Criteria: - Pregnant or breast-feeding - Seeking or in treatment for substance use disorder or under court ordered abstinence - Medications, medical disorders or conditions that could affect study outcome or subject safety - Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine - Positive breath alcohol (BrAC) reading on arrival at any study visit - Actively suicidal (within previous year) - Left-handed or ambidextrous (for fMRI Arm only)


NCT ID:

NCT03648840


Primary Contact:

Principal Investigator
Martin H Plawecki, MD, PhD
Psychiatry, Indiana University School of Medicine

Ann E Kosobud, PhD
Phone: 3172740087
Email: akosobud@iupui.edu


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States

Study Recruiter
Phone: 317-948-6551
Email: erptest@iupui.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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